Systems and methods for automated monitoring and replenishment of genetic material reserves

ABSTRACT

A meter value that reflects the amount of genetic material stored in a reserve is stored in a database for each reserve in a bank. Meter values allow a user to track the amount of genetic material in the reserves of a bank without needing to physically measure or disturb the reserves unnecessarily. As users withdraw and deposit genetic material from and into a reserve, the meter value is changed to reflect the change in the amount of genetic material in the reserve. In certain embodiments, the use of meter values enables accurate and instant accounting of a large number of reserves of genetic material for a large number of individuals. Users and/or individuals may be notified when a meter value falls below a threshold. Notifications may prompt a user to generate additional genetic material from biological sample or an individual to provide additional biological sample.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/453,481, filed Feb. 1, 2017 and U.S. Provisional Application No.62/584,603, filed Nov. 10, 2017, the contents of each of which arehereby incorporated by reference herein in their entirety.

FIELD OF THE INVENTION

This invention relates generally to systems and methods for facilitatingmonitoring and replenishment of stored genetic material.

BACKGROUND OF THE INVENTION

Genomes hold much valuable information that can be used to betterunderstand biological characteristics and traits of humans and animals.Much research is being conducted to establish relationships between thehuman genome and biological characteristics and traits, in particular.Single nucleotide polymorphisms (SNPs) are specific sites identified inparticular genes that influence biological characteristics and traitsdifferent depending on the particular polymorphism of an individual.Different polymorphisms of the nucleotides at a specific site influencethe relevant characteristic or trait differently. The influence of anindividual's polymorphism on his/her trait can be positive or negative.Many relationships between the variants of SNPs and their correspondingbiological characteristics and traits have been established and manymore possible relationships are currently undiscovered and underinvestigation.

Until recently, characterizing a genome was prohibitively expensive suchthat very few individual genomes had been fully or partiallycharacterized. Techniques utilized in genotyping a genome requiredsignificant resources that limited genotyping to laboratory use inscientific research and related areas. Developments of cost-effectiveequipment and procedures for genotyping have made personal genotypingfeasible. The output of genetic information from such genotypingprocedures still requires expertise in the biological sciences tounderstand.

In order for individuals to gain an understanding of their genome, theymay provide biological samples to an organization for genotyping. Theindividual can obtain their biological sample in any number of ways andsend it to the organization. One or more assays are run to at leastpartially genotype the individual based on genetic material extractedfrom the biological sample. Typical genetic testing depletes thebiological sample provided by an individual. In certain research orcommercial settings, biological sample and/or genetic material isretained in order to allow for future genetic experiments or tests(e.g., genotyping) to be performed in the future. Each experiment ortest uses some amount of genetic material, which slowly depletes theamount stored. Complete depletion of stored genetic material preventsfurther genetic testing from being performed, requiring an individual toprovide an additional biological sample or additional genetic materialto be derived from remaining stored biological sample.

Individuals may also have biological sample material stored in cellrepositories for purposes of supporting regenerative medicine. Forexample, induced pluripotent stem cells (iPS cells) may be produced froma blood sample (or other biological substance sample), then stored in arepository for ongoing and/or future use.

There is a need for systems and methods that facilitate storage ofgenetic material used for genomic research and genetic testing andtracking of the amount of genetic material stored. By allowing a user(operator) to obtain an assessment of the amount of genetic materialremaining in a store, the user can appropriately plan and conductexperiments and/or tests without interruption to their workflow or delayin providing desired genetic (e.g., genomic) information to individuals.

SUMMARY

Reserves of genetic material are stored in a bank for use in geneticexperiments and/or testing. A meter value that reflects the amount ofgenetic material stored in a reserve is stored in a database for eachreserve in the bank. Meter values allow a user (operator) to track theamount of genetic material in the reserves of a bank without needing tophysically measure or disturb the reserves unnecessarily, which mayotherwise result in a negative change in the state of the geneticmaterial. As users withdraw and deposit genetic material from and into areserve, the meter value is changed to reflect the change in the amountof genetic material in the reserve. In certain embodiments, the use ofmeter values enables accurate and instant accounting of a large numberof reserves of genetic material for a large number of individuals. Usersand/or individuals may be notified when a meter value falls below athreshold. Notifications may prompt a user to generate additionalgenetic material from biological sample or an individual to provideadditional biological sample.

In one aspect, the invention is directed to a method of monitoring(e.g., automatically) amounts of genetic material (e.g. DNA, e.g. RNA)stored in a reserve of genetic material extracted from biologicalsamples of individuals (e.g. saliva, e.g. blood, e.g. tissue, e.g. cheekcells (e.g. collected via a cheek (buccal) swab, e.g. urine, e.g. hair,e.g. induced pluripotent stem cells generated from adult cells ofindividuals), the method comprising: for each of a plurality ofindividuals whose genetic material is contained in a bank, storing, by aprocessor of a computing device, a meter value that reflects an amount(e.g. grams, e.g., ng, e.g. mols, e.g., nmols, e.g. microliters (i.e.when genetic material is the solute in a solution of fixedconcentration)) of the genetic material stored in a reserve of eachindividual's genetic material (e.g. the meter value is an estimatedamount of genetic material stored in the reserve; e.g. the meter valueis an estimated lower bound corresponding to an estimated minimum amountof genetic material stored in the reserve); and for each of one or morewithdrawals or deposits of genetic material from/into the bank,updating, by the processor, the meter value of corresponding reserve(s)of genetic material to reflect an amount (e.g. grams, e.g., ng, e.g.mols, e.g., nmols) of genetic material remaining in the correspondingreserve(s).

In certain embodiments the method further comprises: determining, by theprocessor, for each of a plurality of reserves in the bank, whether themeter value is below a minimum threshold of an amount of geneticmaterial to be maintained in the reserve of an individual; andresponsive to determining that the meter value is below a minimumthreshold value for a given reserve, triggering, by the processor, anotification (e.g., a graphical rendering in a software application)(e.g., that collection of additional genetic material from theindividual associated with the reserve is needed) (e.g., that displaysthe meter value of each reserve for which the meter value is below theminimum threshold). In certain embodiments, the triggering of thenotification comprises issuing an alert [e.g. an email, e.g. a textmessage, e.g. an in-app notification, e.g. a push notification sent to acomputing device (e.g. a smartphone, e.g. a tablet computer) of theindividual associated with the reserve] of low reserve amount (e.g.wherein the alert comprises an identification of the reserve and/or theindividual associated with the reserve, e.g. wherein the alert comprisesthe meter value).

In certain embodiments, triggering of the notification comprisesautomatically issuing, by the processor, a request to supply theindividual associated with the reserve with a kit for providing areplenishment biological sample (e.g. to an inventory management system,e.g., to an order fulfillment center).

In certain embodiments, the kit comprises instruments for collection ofthe replenishment biological sample from the individual associated withthe reserve [e.g., wherein the kit comprises one or more instrumentsselected from the group consisting of: (A) an instrument for collectingcheek cells (e.g., one or more cheek (buccal) swabs); (B) an instrumentfor collecting a saliva sample (e.g., a saliva collection tube); (C) aninstrument for collecting a blood sample (e.g., a syringe and bloodcollection tube; e.g., a portable phlebotomy kit; e.g., a home fingerprick kit); (D) an instrument for collecting a urine sample (e.g., aurine specimen cup); and (E) an instrument for collecting a hairsample].

In certain embodiments, the kit comprises one or more cheek (buccal)swabs.

In certain embodiments, the kit comprises a prepaid, preaddressedmailing envelope for sending the replenishment biological sample to afacility for processing (e.g., extraction of genetic material; e.g.,derivation of iPSCs therefrom) and/or storage.

In certain embodiments, the kit comprises a label comprising ananonymous identifier [e.g., an alphanumeric code; e.g., a graphical code(e.g., a barcode; e.g., a Quick Response (QR) code)] that identifies thereserve of genetic material associated with individual [e.g., butcomprises no other identifying information about the individual (e.g.,such that the anonymous identifier label obscures the individual'sidentity)].

In certain embodiments, the method comprises providing (e.g., mailing)the kit to the individual.

In certain embodiments, the method further comprises, responsive todetermining that the meter value is below a minimum threshold value fora given reserve, replenishing the given reserve with additional geneticmaterial extracted from a biological sample from the individualassociated with the reserve (e.g., a stored biological sample from theindividual associated with the reserve; e.g., a replenishment biologicalsample provided by the individual associated with the reserve). Incertain embodiments, the additional genetic material is extracted frominduced pluripotent stem cells generated from adult cells [e.g.fibroblasts (e.g. obtained via a skin biopsy), e.g. keratinocytes (e.g.obtained from a hair sample), e.g. blood cells, e.g. renal epithelialcells (e.g. obtained from a urine sample)] from the individualassociated with the reserve.

In certain embodiments, the method comprises, initially (e.g. prior toperforming any measurements using the genetic material stored in thereserve): for each of a plurality of individuals, receiving (e.g.,determining), by the processor, an initial value reflecting an amount ofgenetic material initially present in the reserve of genetic materialassociated with the individual (e.g. the initial value is an estimatedamount of genetic material initially present in the reserve; e.g. theinitial value is an estimated lower bound corresponding to an estimatedminimum amount of genetic material initially present in the reserve);and storing, by the processor, the received initial value as the metervalue. In certain embodiments, the initial value is based on an amountof genetic material extracted from a corresponding biological samplefrom the individual associated with the reserve and deposited in thereserve (e.g. an estimated amount of genetic material extracted from thecorresponding biological sample; e.g. an estimated lower boundcorresponding to an estimated minimum amount of genetic materialextracted from the corresponding biological sample).

In certain embodiments, the method comprises, for each of the one ormore withdrawals (e.g., withdrawals for purposes of conducting a genetictest): receiving (e.g. determining), by the processor, a usage valuethat reflects the amount (e.g. grams, e.g. mols) of genetic materialremoved in the withdrawal; and updating, by the processor, the metervalue for the corresponding reserve using the usage value.

In another aspect, the invention is directed to a system for monitoring(e.g., automatically) amounts of genetic material (e.g. DNA, e.g. RNA)stored in a reserve of genetic material extracted from biologicalsamples of individuals (e.g. saliva, e.g. blood, e.g. tissue, e.g. cheekcells (e.g. collected via a cheek (buccal) swab, e.g. urine, e.g. hair,e.g. induced pluripotent stem cells generated from adult cells ofindividuals), the system comprising: a processor; and a non-transitorycomputer readable memory having instructions stored thereon, wherein theinstructions, when executed by the processor, cause the processor to:for each of a plurality of individuals whose genetic material iscontained in a bank, store, by the processor, a meter value thatreflects an amount (e.g. grams, e.g., ng, e.g. mols, e.g., nmols, e.g.microliters (i.e. when genetic material is the solute in a solution offixed concentration)) of the genetic material stored in a reserve ofeach individual's genetic material (e.g. the meter value is an estimatedamount of genetic material stored in the reserve; e.g. the meter valueis an estimated lower bound corresponding to an estimated minimum amountof genetic material stored in the reserve); and for each of one or morewithdrawals or deposits of genetic material from/into the bank, update,by the processor, the meter value of corresponding reserve(s) of geneticmaterial to reflect an amount (e.g. grams, e.g., ng, e.g. mols, e.g.,nmols) of genetic material remaining in the corresponding reserve(s).

In certain embodiments, the instructions, when executed by theprocessor, cause the processor to: determine, by the processor, for eachof a plurality of reserves in the bank, whether the meter value is belowa minimum threshold of an amount of genetic material to be maintained inthe reserve of an individual; and responsive to determining that themeter value is below a minimum threshold value for a given reserve,trigger, by the processor, a notification (e.g., a graphical renderingin a software application) (e.g., that collection of additional geneticmaterial from the individual associated with the reserve is needed)(e.g., that displays the meter value of each reserve for which the metervalue is below the minimum threshold). In certain embodiments, theinstructions, when executed by the processor, cause the processor to:when triggering the notification, issue an alert [e.g. an email, e.g. atext message, e.g. an in-app notification, e.g. a push notification sentto a computing device (e.g. a smartphone, e.g. a tablet computer) of theindividual associated with the reserve] of low reserve amount (e.g.wherein the alert comprises an identification of the reserve and/or theindividual associated with the reserve, e.g. wherein the alert comprisesthe meter value).

In certain embodiments, the instructions, when executed by theprocessor, cause the processor to: when triggering the notification,automatically issue, by the processor, a request to supply theindividual associated with the reserve with a kit for providing areplenishment biological sample (e.g. to an inventory management system,e.g., to an order fulfillment center).

In certain embodiments, the kit comprises instruments for collection ofthe replenishment biological sample from the individual associated withthe reserve [e.g., wherein the kit comprises one or more instrumentsselected from the group consisting of: (A) an instrument for collectingcheek cells (e.g., one or more cheek (buccal) swabs); (B) an instrumentfor collecting a saliva sample (e.g., a saliva collection tube); (C) aninstrument for collecting a blood sample (e.g., a syringe and bloodcollection tube; e.g., a portable phlebotomy kit; e.g., a home fingerprick kit); (D) an instrument for collecting a urine sample (e.g., aurine specimen cup); and (E) an instrument for collecting a hairsample].

In certain embodiments, the kit comprises one or more cheek (buccal)swabs.

In certain embodiments, the kit comprises a prepaid, preaddressedmailing envelope for sending the replenishment biological sample to afacility for processing (e.g., extraction of genetic material; e.g.,derivation of iPSCs therefrom) and/or storage.

In certain embodiments, the kit comprises a label comprising ananonymous identifier [e.g., an alphanumeric code; e.g., a graphical code(e.g., a barcode; e.g., a Quick Response (QR) code)] that identifies thereserve of genetic material associated with individual [e.g., butcomprises no other identifying information about the individual (e.g.,such that the anonymous identifier label obscures the individual'sidentity)].

In certain embodiments, the instructions, when executed by theprocessor, cause the processor to, initially (e.g. prior to performingany measurements using the genetic material stored in the reserve): foreach of a plurality of individuals, receive (e.g., determining), by theprocessor, an initial value reflecting an amount of genetic materialinitially present in the reserve of genetic material associated with theindividual (e.g. the initial value is an estimated amount of geneticmaterial initially present in the reserve; e.g. the initial value is anestimated lower bound corresponding to an estimated minimum amount ofgenetic material initially present in the reserve); and store, by theprocessor, the received initial value as the meter value. In certainembodiments, the initial value is based on an amount of genetic materialextracted from a corresponding biological sample from the individualassociated with the reserve and deposited in the reserve (e.g. anestimated amount of genetic material extracted from the correspondingbiological sample; e.g. an estimated lower bound corresponding to anestimated minimum amount of genetic material extracted from thecorresponding biological sample).

In certain embodiments, the instructions, when executed by theprocessor, cause the processor to, for each of the one or morewithdrawals (e.g., withdrawals for purposes of conducting a genetictest): receive (e.g. determining), by the processor, a usage value thatreflects the amount (e.g. grams, e.g. mols) of genetic material removedin the withdrawal; and update, by the processor, the meter value for thecorresponding reserve using the usage value.

BRIEF DESCRIPTION OF THE FIGURES

The foregoing and other objects, aspects, features, and advantages ofthe present disclosure will become more apparent and better understoodby referring to the following description taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is a block diagram illustrating associations between differentdata structures provided in accordance with the systems and methodsdescribed herein, according to an illustrative embodiment;

FIG. 2 is a block diagram showing an organizational hierarchy of apersonal genetic profile product, according to an illustrativeembodiment;

FIG. 3A is a screenshot showing a homescreen of a graphical userinterface (GUI) that a user uses to view different products thatsummarize their genetic profile, according to an illustrativeembodiment;

FIG. 3B is a screenshot of the GUI of FIG. 3A showing the interface thatappears when a particular product is selected, according to anillustrative embodiment;

FIG. 3C is a screenshot of the GUI showing a summary of the product thatappears when the information (“i”) button of FIG. 3B is selected,according to an illustrative embodiment;

FIG. 3D is a screenshot of the GUI of FIG. 3A showing the interface thatappears when a particular category of the selected product is selected,according to an illustrative embodiment;

FIG. 3E is a screenshot of the GUI of FIG. 3A showing the interface thatappears when a particular SNP object of the selected category isselected, according to an illustrative embodiment;

FIG. 3F is a screenshot of the GUI showing further additionalinformation that can be viewed by scrolling when the particular SNPobject is selected, according to an illustrative embodiment;

FIG. 3G is a screenshot of the GUI showing further additionalinformation that can be viewed by scrolling further when the particularSNP object is selected, according to an illustrative embodiment;

FIG. 3H is a screenshot of the GUI showing a summary of the categorythat appears when the information (“i”) button of FIG. 3D is selected,according to an illustrative embodiment;

FIG. 4 is a block diagram showing a process for creating a personalgenetic profile assessment, according to an illustrative embodiment;

FIG. 5 is portion of a text file comprising genotyping data, accordingto an illustrative embodiment;

FIG. 6 is a block diagram showing a process for automated monitoring andreplenishment of genetic material reserves, according to an illustrativeembodiment.

FIG. 7 is a block diagram of an exemplary cloud computing environment,used in certain embodiments.

FIG. 8 is a block diagram of an example computing device and an examplemobile computing device used in certain embodiments

The features and advantages of the present disclosure will become moreapparent from the detailed description set forth below when taken inconjunction with the drawings, in which like reference charactersidentify corresponding elements throughout. In the drawings, likereference numbers generally indicate identical, functionally similar,and/or structurally similar elements.

Definitions

In order for the present disclosure to be more readily understood,certain terms used herein are defined below. Additional definitions forthe following terms and other terms may be set forth throughout thespecification.

In this application, the use of “or” means “and/or” unless statedotherwise. As used in this application, the term “comprise” andvariations of the term, such as “comprising” and “comprises,” are notintended to exclude other additives, components, integers or steps. Asused in this application, the terms “about” and “approximately” are usedas equivalents. Any numerals used in this application with or withoutabout/approximately are meant to cover any normal fluctuationsappreciated by one of ordinary skill in the relevant art. In certainembodiments, the term “approximately” or “about” refers to a range ofvalues that fall within 25%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%,12%, 11%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, or less in eitherdirection (greater than or less than) of the stated reference valueunless otherwise stated or otherwise evident from the context (exceptwhere such number would exceed 100% of a possible value).

Organization: As used herein, the term “organization” refers to anentity that performs genetic tests or otherwise uses or consumes storedbiological samples and/or genetic material. The entity may be a company,individual, research group, research laboratory, non-profitorganization, laboratory, hospital, medical organization, or medicaltesting facility. In certain embodiments, an organization performsgenetic tests for research purposes. In certain embodiments, anorganization performs genetic tests as a service or part of a servicerequested or purchased by an individual. In certain embodiments, thegenetic tests an organization performs are genotyping tests.

Bank: As used herein, the term “bank” refers to a system, apparatus, orlocation where genetic material and/or biological sample is stored.Genetic material may be derived (e.g., extracted) from a biologicalsample provided by an individual to the organization that owns and/oroperates the bank. In certain embodiments, biological samples are storedin a bank separate from a bank that stores genetic material extractedtherefrom.

Individual: As used herein, the term “individual” refers to someone whoprovides a biological sample to an organization for use in genetictesting and/or experimentation. In certain embodiments, an individualuses an assessment graphical user interface in order to view informationabout a genome. The individual may supply one or more biological samplesto be genotyped in order for a personal genetic profile assessment to beformed. The individual may purchase or be given access to one or moreproducts in order to view a personal genetic profile assessment.

User: As used herein, the term “user” refers to someone associated withan organization who conducts and/or assists in conducting genetictesting and/or experimentation. In certain embodiments, a user isemployed by an organization.

Reserve: As used herein, the term “reserve” refers to an amount ofgenetic material stored in a bank.

Meter value: As used herein, the term “meter value” refers to a valuethat reflects the amount of genetic material in a reserve stored in abank. A meter value may be a percentage of a maximum capacity for areserve, a value empirically measured or estimated from the amount ofgenetic material in a reserve, or a value that indicates fullness of thecapacity of a reserve (e.g., a number on a scale from 1-5 or 1-10).

Variant: As used herein, the terms “variant” refers to a specificvariation of a specific SNP occurring in the genetic material of apopulation. In certain embodiments, a variant is a specific combinationof a first allele of a first copy of an individual's genetic material(e.g. corresponding to an individual's paternal DNA) and a second alleleof a second copy of an individual's genetic material (e.g. correspondingto an individual's maternal DNA), as occurs in diploid organisms (e.g.humans).

Qualifier: As used herein, the term “qualifier” refers to aclassification (e.g. a label) of a particular variant of a given SNP.The qualifier associated with a given variant is the particularclassification (e.g. label) of that variant. For example, a givenvariant may be associated with a particular qualifier of a predefinedset of possible qualifiers. For example, a given variant may beassociated with a qualifier selected from a group of labels such as“Adapt,” “Normal,” and “Gifted.” In certain embodiments, for a givenvariant of a given SNP, a qualifier corresponds to a classification ofthe given variant based on (i) the prevalence of the given variantwithin a population (e.g. if the variant is common, e.g. if the variantis rare) and/or (ii) a health-related phenotype associated with thevariant. For example, a common variant may be associated with thequalifier “Normal”. A rare variant that confers a disadvantageousphenotype, such as a predisposition to high cholesterol, may beassociated with the qualifier “Adapt” (e.g. classified as rare anddisadvantageous). A rare variant that confers an advantageous phenotype,such as a predisposition to lower cholesterol, may be associated withthe qualifier “Gifted” (e.g. accordingly, the variant is classified asrare and advantageous).

Variant object: As used herein, the term “variant object” refers to adata structure corresponding to (e.g. that is used to represent) aspecific variant of a physical SNP and/or gene within a given genome(e.g., the genome of a human).

SNP object: As used herein, the term “SNP object” refers to a datastructure corresponding to (e.g. that is used to represent) a specificsingle nucleotide polymorphism (SNP). In certain embodiments, a SNPobject comprises a SNP reference that identifies the specific SNP towhich the SNP object corresponds. The SNP reference may be analphanumeric code such as an accepted name of the SNP or otheridentifying mark or label capable of being stored electronically. TheSNP reference may be an alphanumeric code such as a National Center forBiotechnology Information (NCBI) database reference number.

Gene object: As used herein, the term “gene object” refers to a datastructure corresponding to (e.g. that is used to represent) a specificphysical gene within a given genome (e.g. the human genome).

Genotyping data: As used herein, the term “genotyping data” refers todata obtained from measurements of a genotype. Measurements of agenotype performed on a biological sample identify the particularnucleotide(s) (also referred to as “bases”) that is/are incorporated atone or more particular positions in genetic material extracted from thebiological sample. Accordingly, genotyping measurements for a particularindividual are measurements performed on a biological sample of from theindividual, and which identify the particular nucleotides present at oneor more specific positions within their genome.

Genotyping data may be measurements of particular genes (e.g., portionsof an individual's genetic sequence, e.g., DNA sequence), or SNPs. Forexample, a genotyping measurement of a particular SNP for an individualidentifies the particular variant of that SNP that the individual has. Agenotyping measurement of a particular gene for an individual identifiesthe particular nucleotides that are present at one or more locationswithin and/or in proximity to the gene for the individual. For example,genotyping measurements of a particular gene may identify the particularvariants of one or more SNPs associated with a particular gene.

In certain embodiments, genotyping data is obtained from a multi-genepanel. In certain embodiments, genotyping data is obtained from assays(e.g., TaqMan™ assays) that detect one or more specific variants ofspecific SNPs. In certain embodiments, genotyping data is obtained fromgenetic sequencing measurements. In certain embodiments, genotyping datais generated in response to a purchase or request by an individual. Incertain embodiments, genotyping data comprises data for a portion of agenotype (e.g., of an individual). In certain embodiments, genotypingdata comprises all available measurements of a genotype (e.g., of anindividual).

Category: As used herein, the term “category” refers to a data structurecorresponding to (e.g. that is used to represent) a particularhealth-related trait or characteristic.

Product, Genetic Profile Product, Personal Genetic Profile Product: Asused herein, the terms “product,” “genetic profile product,” and“personal genetic profile product,” refer to a data structurecorresponding to (e.g. that is used to represent) a general class ofhealth-related traits and/or characteristics. In certain embodiments aproduct is associated with one or more categories that correspond tohealth-related traits and characteristics related to the general classof health-related traits and characteristics to which the productcorresponds.

Graphical Control Element: As used herein, the term “graphical controlelement” refers to an element of a graphical user interface element thatmay be used to provide user and/or individual input. A graphical controlelement may be a textbox, dropdown list, radio button, data field,checkbox, button (e.g., selectable icon), list box, or slider.

Associate, Associated with: As used herein, the terms “associate,” and“associated with,” as in a first data structure is associated with asecond data structure, refer to a computer representation of anassociation between two data structures or data elements that is storedelectronically (e.g. in computer memory).

Provide: As used herein, the term “provide”, as in “providing data”,refers to a process for passing data in between different softwareapplications, modules, systems, and/or databases. In certainembodiments, providing data comprises the execution of instructions by aprocess to transfer data in between software applications, or in betweendifferent modules of the same software application. In certainembodiments a software application may provide data to anotherapplication in the form of a file. In certain embodiments an applicationmay provide data to another application on the same processor. Incertain embodiments standard protocols may be used to provide data toapplications on different resources. In certain embodiments a module ina software application may provide data to another module by passingarguments to that module.

DESCRIPTION OF THE INVENTION

Presented herein are systems and methods related for automaticallymonitoring amounts of genetic material contained in a bank thatcomprises genetic material of a plurality of individuals.

Meter Values and Storage of Biological Samples and Genetic Material

An individual provides a biological sample to an organization for use incharacterizing genetic characteristics of genetic material contained inthe biological sample. The individual takes one or more biologicalsamples to provide to the bank. Biological samples may be, for example,saliva, blood, tissue, cheek cells, urine, hair, or induced pluripotentstem cells (iPSCs) generated from adult cells. Such biological samplesmay be taken by any commonly known method such as, for example, a cheekswab. Biological samples may be biological samples of the individual orthey may belong to a person or animal related to the individual. In someembodiments, biological samples are from a non-human animal. Forexample, an individual may supply a biological sample of their pet inorder to understand genomic information about the pet to assist inproviding better care. The animal may be a pet or may be an animal caredfor by an individual. For example, the individual may be a veterinarianor a caretaker at a zoo charged with caring for the animal. In someembodiments, an individual provides a biological sample of a ward towhom the individual is a guardian. For example, a parent may supply abiological sample to understand genomic information about his/her childin order to improve his/her childrearing.

Individuals may also have biological sample material stored in cellrepositories for purposes of supporting regenerative medicine. Forexample, induced pluripotent stem cells (iPS cells) may be produced froma blood sample (or other biological substance sample), then stored in arepository for ongoing and/or future use.

Biological samples contain genetic material (e.g., DNA, RNA) that can becharacterized by the organization. During processing and for any lengthof time after, genetic material derived from biological samples may bestored in a bank. In certain embodiments, an individual provides abiological sample to a company in order for the company to extract DNAfrom the biological sample for use in genotyping. In certainembodiments, the extracted DNA is stored in a bank when not in use.

An organization may store the genetic material of a large number ofindividuals for a prolonged period of time. A large bank of geneticmaterial requires an accurate record of the amount of genetic materialstored for reference in planning, conducting, and logging genetic tests,assays, or other related experiments. The accurate record may be adatabase or array stored electronically on a computer for referenceusing a computer (e.g., over a web interface or on a locally run pieceof software).

A database or array will store a meter value that reflects the amount ofgenetic material in a bank for each individual for which geneticmaterial has been extracted (i.e., from a biological sample). In thisway, a user can view a database (e.g., visualized on a display) thatindicates the meter value for each individual with genetic material inthe bank in order to monitor the amount of genetic material of one ormore individuals possessed by the organization.

A meter value is a value that reflects the reserve of an individual'sgenetic material as stored. The meter value may be stored as a value inany conventional unit that reflects the amount available in the bank.For example, the meter value may be a value in grams, nanograms, moles,nanomoles, liters, milliliters, microliters, or similar. In certainembodiments, a meter value is stored in nanograms. In certainembodiments, a meter value is stored in microliters. When a meter valueis stored in a volumetric unit, a standard concentration of the geneticmaterial in a solvent may be used by an organization such that the metervalue is proportional to the amount of genetic material stored in thebank. In certain embodiments, the meter value is an estimate of theamount of genetic material (i.e., the meter value is an average, median,or similar statistical estimator of the amount stored in the bank asderived from the usage history of the reserve of the individual'sgenetic material). The meter value may be an estimated lower boundcorresponding to an estimated minimum amount of genetic material storedin the reserve.

A meter value is updated when the amount of genetic material in a bankchanges. The amount of genetic material in a bank may change due to awithdrawal or deposit from the bank. For example, genetic material iswithdrawn from a bank when a user runs an experiment or test (e.g., anassay) on the genetic material. In certain embodiments, the meter valueof a reserve is lowered by a set amount for each withdrawal for a testdue to each test requires a fixed amount of genetic material. In certainembodiments, a user runs a PCR-based SNP genotyping assay (e.g., aTaqMan™ SNP genotyping assay).

Genotyping Assays and Storage and Presentation of Genetic ProfileAssessments

In certain embodiments, a genotyping assay is performed by a user asprompted by an individual's request for additional genomic information.For example, as described herein, genotyping assays that result inwithdrawals of genetic material from the bank may occur when theindividual purchases or is given access to additional products in apersonal genetic profile assessment. As described herein, personalgenetic profile products represent genotyping assays that measure setsof related (e.g., in terms of the various health related phenotypes thatthey influence) SNPs. As individuals purchase various genotyping assaysrepresented by products in order to, e.g., find out different types ofinformation about their unique genetic makeup, genetic material fromtheir reserves in the bank in order to perform the purchased genotypingassays.

In certain embodiments, performing such genotyping assays, creatingindividual personal genetic profile assessments, and presentinginformation to an individual is facilitated by a flexible andhierarchical data structure framework. Approaches for performinggenotyping assays and creating personal genetic profile assessmentsusing flexible data structure frameworks and organization of genotypingassays based on products are also described in PCT Application No.PCT/US17/67264, filed Dec. 19, 2017, and PCT Application No.PCT/US17/67272, filed Dec. 19, 2017, the contents of each of which arehereby incorporated by reference herein in their entirety.

A. Flexible Data Structure Framework

Turning to FIG. 1 , in certain embodiments, in order to provide anindividual not only with their personal genetic profile assessment, butalso convey information related to the particular traits andcharacteristics that are influenced by the specific SNP variants presentin their genetic material in an organized and intuitive fashion, thesystems and methods described herein provide a framework comprising anintuitive hierarchical organization of data structures. The frameworkprovides for storing relationships (e.g. associations) betweenparticular SNPs, health-related traits and characteristics, and generalclasses of such health-related traits and characteristics, based on thespecific phenotypes that each particular SNP influences.

In certain embodiments, a first class of data structures, referred toherein as products, are used to represent different general classes ofhealth-related traits and characteristics. In certain embodiments, aproduct data structure corresponds to a particular assessment ordered(e.g., purchased by the individual), in which unique versions of genesand/or SNPs that an individual has that influence the particular generalclass of health-related traits and characteristics that thecorresponding product represents are identified (e.g., via genotypingmeasurements). In certain embodiments, each product has a name (e.g. aproduct data structure comprises a name (e.g. text data representing thename)) that provides a convenient, and memorable way to refer to theproduct. For example, a particular product 112 (e.g. named “FUEL™”) isused to represent a class of traits corresponding to the way in which anindividual's body processes different foods and nutrients. Anotherproduct 114 (e.g. named “AURA™”) is used to represent a class of traitscorresponding to skin health. Another product 116 (e.g. named“FITCODE™”) is used to represent a class of traits corresponding tophysical fitness. Another product 118 (e.g. named “SUPERHERO™”) is usedto represent a class of traits corresponding to physical andintellectual performance. In certain embodiments, a name of a product isthe same as the name under which a particular assessment is offered forsale. For example, assessments FUEL™, FITCODE™, AURA™ and SUPERHERO™ areoffered for sale by Orgi3n, Inc. of Boston Mass.

In certain embodiments, each product is in turn associated with one ormore of a second class of data structures, referred to as categories. Incertain embodiments, each category corresponds to a particularhealth-related trait or characteristic (e.g. food sensitivity, foodbreakdown, hunger and weight, vitamins, skin uv sensitivity, endurance,metabolism, joint health, muscle strength, intelligence). In certainembodiments, the categories with which a particular product isassociated each correspond to different health-related traits orcharacteristics that are related to the general class of health-relatedtraits or characteristics to which the particular product corresponds(e.g. the general class of health-related traits or characteristics thatthe product represents). As with products, in certain embodiments, eachcategory has a name (e.g. a category data structure comprises a name(e.g. text data representing the name)) that provides a convenient, andmemorable way to refer to the category.

In turn, each category is associated with one or more SNP objects, eachSNP object corresponding to a specific SNP. Each SNP object associatedwith a particular category corresponds to a specific SNP that influencesa specific health related phenotype that relates to the trait orcharacteristic to which the particular category corresponds. Each SNPobject may identify the specific SNP to which it corresponds via a SNPreference that the SNP object comprises. The SNP reference may be analphanumeric code such as an accepted name of the SNP or otheridentifying mark or label capable of being stored electronically. TheSNP reference may be an alphanumeric code such as a National Center forBiotechnology Information (NCBI) database reference number.

For example, the schematic of FIG. 1 shows an example of series ofproducts, categories, and SNP objects that are associated with eachother. Associated gene objects, to be described in the following, arealso shown. The different products and categories are identified bytheir particular names, and the SNP objects each are identified by arespective SNP reference each comprises. In the example of FIG. 1 , theSNP references are NCBI database reference numbers.

The “FUEL™” product 112 is associated with categories such as “FoodSensitivity” 122, “Food Breakdown” 124, “Hunger and Weight” 126, and“Vitamins” 128. Several SNP objects corresponding to specific SNPs thatinfluence phenotypes related to an individual's sensitivity to differenttypes of foods, and, accordingly, are associated with the “FoodSensitivity” category 122 are shown. In FIG. 2 , the lines connectingthe SNP objects to different categories indicate the association of eachparticular SNP object with one or more different categories. Theassociations may be direct associations or indirect associations (e.g.,through mutual association with an intermediate data structure notshown).

For example, SNP object 132 corresponds to the rs671 SNP, whichinfluences the manner in which an individual processes alcohol. Inparticular, depending on the particular variant of the rs671 SNP that anindividual has, the individual may process alcohol normally, or beimpaired in their ability to process alcohol, and likely suffer fromadverse effects resulting from alcohol consumption, such as flushing,headaches, fatigue, and sickness. Accordingly, providing an individualwith knowledge of the particular variant of the rs671 SNP that they havemay allow them to modify their behavior accordingly, for example, bybeing mindful of the amounts of alcohol that they consume (e.g. on aregular basis, e.g. in social settings).

Other SNP objects corresponding to SNPs that influence food sensitivityrelated phenotypes, and, accordingly, are associated with the “FoodSensitivity” category 222 are shown. For example, SNP object 144corresponds to the rs762551 SNP that influences caffeine metabolism, SNPobject 146 corresponds to the rs4988235 SNP that influences lactoseintolerance, and SNP object 148 corresponds to the rs72921001 SNP thatinfluences an aversion to the herb Cilantro (e.g. depending on theparticular variant of this SNP that an individual has, they may eitherperceive Cilantro as pleasant tasting, or bitter and soap-like intaste).

In certain examples, multiple SNPs are associated with a particularphenotype and, accordingly, the SNP objects to which they correspond maybe grouped together. For example, three SNPS—rs713598 (corresponding toSNP object 150 a), rs10246939 (corresponding to SNP object 150 b), andrs1726866 (corresponding to SNP object 150 c), —influence thesensitivity of an individual to bitter tasting foods (e.g. cabbage,broccoli, cauliflower, kale, brussel sprouts, and collard greens), and,accordingly, their enjoyment of or aversion to such foods.

SNPs correspond to specific locations within or nearby (e.g. a SNP mayoccur in a promotor region that influences transcription of a particulargene, e.g. a SNP may occur within 5 kb upstream or downstream of aparticular gene, e.g. a SNP may occur within 100 kb upstream ordownstream of a particular gene, e.g. a SNP may occur within 500 kbupstream or downstream of a particular gene, e.g. a SNP may occur within1 Mb upstream or downstream of a particular gene) genes in anindividual's genetic material. Accordingly, in certain embodiments, asshown in FIG. 1 , each SNP object is associated with a gene object thatcorresponds to the particular gene within or nearby to which the SNP towhich the SNP object corresponds is present. For example, the rs671 SNPcorresponds to a location within the ALDH2 gene; the rs762551 SNPcorresponds to a location within the CYP1A2 gene, the rs4988235 SNPoccurs within the MCM6 gene, and the rs72921001 SNP occurs within theOR10A2 gene. Accordingly, SNP object 142 (corresponding to the rs671SNP) is associated with gene object 162 (corresponding to the ALDH2gene). Similarly, SNP object 144 (corresponding to the rs762551 SNP) isassociated with gene object 162 (corresponding to the CYP1A2 gene), SNPobject 146 (corresponding to the rs4988235 SNP) is associated with geneobject 166 (corresponding to the MCM6 gene) and SNP object 148(corresponding to the rs72921001 SNP) is associated with gene object 168(corresponding to the OR10A2 gene).

Other SNPs objects correspond to SNPs that are nearby particular genesof interest and thereby influence phenotypes associated with expressionof the gene. For example, rs12696304 is a SNP that lies 1.5 kbdownstream from the TERC gene, and influences biological agingassociated with the TERC gene. Accordingly, in one example, a SNP objectcorresponding to the rs12696304 SNP is associated a gene objectcorresponding to the TERC gene.

In certain embodiments, multiple SNPs of interest occur within a singlegene. For example, the three SNPs related to bitter taste—rs713598,rs10246939, and rs1726866—occur within the TAS2R38 gene. Accordingly,SNP objects 150 a, 150 b, and 150 c, which correspond to the rs713598,rs10246939, and rs1726866 SNPs, respectively, are all associated with agene object 170 corresponding to the TAS2R38 gene.

In certain embodiments, different products correspond to differentgeneral classes of health-related traits and characteristics. Forexample, products may be based on particular organs (e.g. product 114,named “AURA™”, is related to skin health), or particular habits,activities, or bodily functions. For example, food related biologicalcharacteristics and traits may be covered by a single products or aplurality of products. A single product or a plurality of products maybe based on learning and brain function characteristics and traits. Asingle product or a plurality of products may be based on physicalfitness (e.g., cardiovascular strength, agility, flexibility, muscularstrength).

For example, as shown in FIG. 1 , another product 116 (e.g. named“FITCODE™”), relates to a general class of physical fitness relatedtraits, and, accordingly, comprises categories associated with endurance130 (“Endurance”), metabolism 132 (“Metabolism”), the ability of anindividual to recover effectively following exercises 134 (“ExerciseRecovery”), and cardiovascular fitness and skeletal muscle makeup 136(“Power Performance”).

In certain embodiments, a particular SNP object is associated with twoor more categories. For example, the rs17782313 SNP, occurring in theFTO gene, influences an individual's appetite. Accordingly, as shown inFIG. 1 , the SNP object 152 corresponding to the rs17782313 SNP isassociated with both the “Hunger and Weight” category 126 of the “FUEL™”product, and the “Metabolism” category 132 of the “FITCODE™” product.SNP object 152 is also associated with gene object 172, reflecting thefact that the rs17782313 SNP occurs in the FTO gene. In certainembodiments, as with the rs17782313 SNP object, each of a first categoryand a second category with which a particular SNP object is associatedare associated with a different product. In certain embodiments, aparticular SNP object is associated with a first category and a secondcategory, and both the first category and the second category areassociated with the same product.

For example, the SNP object 154 corresponding to the rs1800795 SNP ofthe IL-6 gene (accordingly, SNP object 154 is associated with geneobject 174, which corresponds to the IL-6 gene) is associated with the“Exercise Recovery” category 134 and the “Power Performance” category136, both of which are associated with the “FITCODE™” product 116. Inaddition, in certain embodiments, a category is associated with two ormore products. For example, the “Power Performance” category 136 isassociated with the “FITCODE™” product 116, as well as the “SUPERHERO™”product 118, which provides an assessment of a general class of traitsrelated to physical and intellectual performance.

Thus, by providing a framework comprising a hierarchical organization ofdata structures corresponding to products, categories, SNP objects, andgene objects, the systems, methods, and architectures described hereinprovide an intuitive and flexible approach to storing, updating, andcreating new associations between different classes of health-relatedtraits and characteristics, and the underlying genetic variationscorresponding to different specific SNPs that influence them.

In certain embodiments the hierarchical organization of product,category, SNP object gene object, and variant object data structuresserves as a flexible template that facilitates both the rapid creationof individual personal genetic profile assessments from genotypingmeasurements taken from a plurality of individuals, and the presentationof an individual's personal genetic profile assessment. In particular,an individual may purchase assessments corresponding to differentproducts, in order to gain insight into the manner in which theirpersonal genome influences the different general classes ofhealth-related traits and characteristics to which each differentproduct corresponds. Accordingly, an individual's personal geneticprofile assessment corresponding to one or more products comprises, foreach specific SNP associated with each category that is associated witheach of the one or more products, an identification of the particularvariant of the specific SNP that the individual has. Typically, theidentification is obtained via one or more genotyping measurementsperformed on a biological sample taken from the individual (e.g. a bloodsample, e.g. a cheek swab sample, e.g. a saliva sample, e.g., a hairsample, e.g., hair follicle cells).

In certain embodiments, an individual may purchase a first assessmentcorresponding to a first product, and provide a biological sample forgenotyping. The individual's biological sample may be stored (e.g.cryogenically frozen). After a period of time, the individual may chooseto purchase additional assessments corresponding to other products, andthe individual's previously stored biological sample may be taken fromstorage for additional genotyping measurements of the additional SNPsthat are associated with the new products. Moreover, in certainembodiments, additional new products may be created over time, and newassessments corresponding to new products offered to and purchased byindividuals. In certain embodiments, as new information related to theinfluence of new and/or existing SNPs on different specific healthrelated phenotypes is elucidated, new SNP objects and gene objects maybe created, and new associations between them and new or existingcategories and/or products established. In certain embodiments, existingpersonal genetic profile assessments of individuals are automaticallyupdated to reflect new information.

In certain embodiments, in order to facilitate the creation andpresentation of individual personal genetic profile assessments (e.g.corresponding to one or more different products) based on the frameworkdescribed above, the product, category, SNP object, and gene object datastructures described herein store a variety of information. In certainembodiments, product, category, SNP object, and gene object datastructures are created and associated as a hierarchy of data structuresto be later associated with the genotyping data of an individual. FIG. 2is a block diagram of a hierarchy of data structures 200 of an examplegenetic profile product. In certain embodiments, a developer creates andstores one or more generic hierarchies of data structures in accordancewith FIG. 2 that define one or more products that may be purchasedand/or accessed by an individual. The hierarchies of data structures aregeneric in that they contain no personal information for any oneindividual, but instead define the collection of genes, SNPs, andvariants that have relevance to the biological characteristics and/ortraits that are encompassed by a product.

An exemplary data structure of each type is shown to be associated withsub-data structures in order to simplify presentation of the figure. Itis understood that data structures may be associated to any number ofother data structures in the hierarchy if the association is consistentwith the associations shown in FIG. 2 . For example, category 220 b isassociated with gene objects 230 a-b while category 220 c may beassociated with one or more gene objects and/or SNP objects, but anysuch associations are not shown. In some embodiments, data structuresmay be created without also forming associations between otherstructures of relevant types. For example, unassociated or partiallyassociated data structures may be created for planning purposes such asduring product or category development (e.g., category 220 a has noassociations yet because its scope has not been determined yet by theuser). For example, unassociated or partially associated data structuresmay be created to allow genotyping data to be associated with relevantgene objects or SNP objects in order to retain the data in a ready touse format in the event that the gene objects and/or SNP objects arelater associated with one or more categories.

Referring now to FIG. 2 , product 210 comprises three categories 220 a-cand additional information 222. Additional information 222 may be a nameof the product, an icon associated with the product, and/or adescription of the product. Category 220 b comprises two gene objects230 a-b, one SNP object 240, and additional information 232. Additionalinformation 232 may comprise a name of the category, a background imageassociated with the category, an icon associated with the category, acategory order identifier, and/or a description of the category. SNPobject 240 is associated with gene object 270. Gene object 230 a isassociated to three SNP objects 242 a-c. Categories may be associateddirectly to SNP objects, such as category 220 b is associated with SNPobject 240, or they may be associated indirectly such as SNP objects 242a-c are associated to category 220 b via gene object 230 a. The abilityto form associations indirectly allows all SNP objects associated with aparticular gene object to be associated with a category by forming asingle association in cases where all SNP objects of a particular geneare relevant to a particular category. The ability to form associationsdirectly allows a particular SNP object to be associated with a categorywithout also forming an association with all other SNP objectsassociated with the gene object associated with the particular SNPobject in cases where only one or a subset of SNP objects of aparticular gene object are relevant to a category.

Gene object 230 a is also associated with additional information 244.Additional information 244 may comprise one or more data structurescomprising information such as a unique gene identifier that correspondsgene object 230 a to a specific physical gene and descriptiveinformation about the corresponding gene. The gene identifier may be analphanumeric code such as an accepted name of the gene or otheridentifying mark or label capable of being stored electronically.Additional information may be stored as a single data structure or aplurality of data structures.

SNP object 242 b is associated with SNP reference 250, and additionalinformation 254. SNP reference 250 is a unique identifier of the SNPthat corresponds the SNP object to a specific physical SNP. The SNPreference may be an alphanumeric code such as an accepted name of thegene or other identifying mark or label capable of being storedelectronically. The SNP reference may be an alphanumeric code such as aNational Center for Biotechnology Information (NCBI) database referencenumber. Additional information 254 may comprise one or more datastructures with other descriptive information about the correspondingSNP.

Variants of a particular SNP can be represented within a correspondingSNP object using various combinations of data elements such as ameasurement outcomes, and qualifiers. For example, a particular variantof a SNP can be identified by a measurement outcome, which is anidentifier, such as an alphanumeric code, that identifies the specificalleles corresponding to the particular variant. For example, ameasurement outcome such as the string “CC” identifies a first variantof the rs762551 SNP in which an individual has a cytosine (C) at thers762551 position in each copy of their genetic material. A measurementoutcome such as the string “AC” identifies a second variant of thers762551 SNP in which an individual has a C in one copy and an adenine(A) in the other at the rs762551 position. A measurement outcome such asthe string “AA” identifies a second variant of the rs762551 SNP in whichan individual has an A at the rs762551 position in each copy of theirgenetic material. A qualifier is an identifier, such as an alphanumericcode, that identifies a classification of a variant, wherein theclassification may be based on the prevalence of the variant within apopulation, a health-related phenotype associated with the variant,and/or other relevant classification bases. Additional information mayalso be included within a SNP object to describe a particular variant.

In certain embodiments, measurement outcomes and qualifiers thatidentify and classify, respectively the same variant are associated witheach other to form a variant object associated with the SNP object. Forexample, variant object 252 a comprises measurement outcome 260,qualifier 262. Variant object 252 a is also comprises additionalinformation 264. Qualifiers may be words or short phrases thatcharacterize the variant. For example, “adapt” may be used tocharacterize variants that are uncommon and/or disadvantageous; “normal”may be used to characterize variants that are common and/or neitheradvantageous nor disadvantage; and “gifted” may be used to characterizevariants that are uncommon and/or advantageous. Additional information264 comprises a description of the variant. For example, the additionalinformation comprises a description of the specific health-relatedphenotype that an individual with the variant represented by variantobject 252 a exhibits or an explanation of the prevalence of thevariant. A SNP object may be associated with a variant object torepresent each variant of the particular SNP to which it corresponds.For example, SNP object is associated with three variant objects 252a-c.

B. Presentation of Individual Personal Genetic Profile Assessments

In certain embodiments, an individual views their genomic informationusing an assessment graphical user interface (assessment GUI) that ispopulated using one or more products (e.g., one or more hierarchies ofdata structures, such as the exemplary hierarchy of FIG. 2 ) and theindividual's personal genetic profile assessment. In certainembodiments, the individual's personal genetic profile assessment isassociated with the one or more products using a plurality ofassociations such that the assessment GUI is populated using theplurality of associations. In some embodiments, the one or more productsare personalized by updating the hierarchies of data structures tocomprise the data of the individual's personal genetic profileassessment such that the assessment GUI is populated using one or moreproducts modified to be personalized to the individual. The assessmentGUI allows individuals to interactively view their genomic informationby navigating through the layers of data structures from the productlevel down to the level of information for individual SNPs. FIGS. 3A-3Hare snapshots of an exemplary assessment graphical user interface thatan individual would use to view their genomic information.

Referring now to FIG. 3A, the screenshot shows a home screen anindividual uses to navigate to specific information about their personalgenetic profile assessment. Three products 304 a-c are visible: “FUEL™”304 a, “AURA™” 304 b, “EXPONENTIAL™” 304 c. Each product corresponds toa different set of genes that determine biological characteristics andtraits. Selector 302 allows the individual to switch between his/her“LifeProfile™” that allows for navigation to specific informationthrough the hierarchy of data structures, whereas Genes allows theindividual to scroll through a listing of all SNPs corresponding toproducts that the individual has purchased or been given access to.

In certain embodiments, an assessment graphical user interface alsoincludes a graphical control element for sharing data corresponding toan individual's personal genetic profile assessment (or a portionthereof) with one or more sharing entities. Sharing entities may beother individuals, people, or services with whom an individual wishes toshare. For example, an individual may wish to share his or her entirepersonal genetic profile assessment with a friend, a spouse, or a socialmedia service. Upon selection of the graphical control element forsharing, one or more graphical control elements may be provided forselecting which portions (e.g., products, categories, or a selected listof individual SNPs and/or genes) of a personal genetic profileassessment an individual would like to share (e.g., in the event thatthe individual would prefer certain portions of his or her personalgenetic profile assessment remain private). In certain embodiments, thedata is in a PDF report generated from the individual's personal geneticprofile assessment.

Selecting a graphical control element for sharing may provide anindividual with additional graphical control elements with which toselect exactly with whom and by what method a personal genetic profileassessment (or portion thereof) is shared. For example, graphicalcontrol elements may be provided for selecting whether to text, email,or post the personal genetic profile assessment (or portion thereof) andother graphical control elements may be provided to allow an individualto select one or more recipients from among his contacts or entercontact information such as a phone number or email address. Forexample, an individual may select only certain friends or followers on asocial media site with whom the personal genetic profile assessment (orportion thereof) is shared.

In certain embodiments, an individual uses a graphical control elementfor sharing in order to give access to other individuals using anassessment graphical user interface for viewing information about theirgenomes. For example, a first individual may use a graphical controlelement for sharing to give access to their personal genetic profileassessment to a spouse, wherein the spouse views the first individual'spersonal genetic profile assessment using an assessment GUI. In certainembodiments, an assessment GUI includes a graphical control element thatan individual uses to select whose personal genetic profile assessmenthe or she is viewing. For example, the spouse may use such a graphicalcontrol element to toggle between viewing his or her own personalgenetic profile assessment and the first individual's personal geneticprofile assessment.

By selecting the “FUEL™” product from the LifeProfile™ listing of FIG.3A, the individual sees the assessment GUI state of FIG. 3B.LifeProfile™ indicator 306 reminds the individual that he/she is usingthe LifeProfile™ navigation system. The information button 308 can beselected to view the brief description associated with the “FUEL™”product in its data hierarchy, as shown in FIG. 3C. Referring again toFIG. 3B, Fuel Report 310 provides space for a summary of theindividual's “FUEL™” product genomic information. Categories 312 a-d maybe selected to view specific genomic information regarding differentaspects of the individual's genome related to food and eating (e.g.,different aspects of the “FUEL™” product). For each of the fourcategories, the individual sees the name of the category, the backgroundimage associated with the category, and the icon associated with thecategory. For example, category 312 a is named Food Sensitivity, wherethe icon is a fork and knife with a slash, and the background imageshows a variety of foods on a table.

Selecting the Food Sensitivity category 312 a brings the individual to aview of the assessment GUI shown in FIG. 3D. The information button 322can be selected to view the brief description associated with the FoodSensitivity category, as shown in FIG. 3H. Referring again to FIG. 3D,the individual may scroll through a list of selectable control elementscorresponding to each of the SNPs related to the category, wherein eachselectable control element comprises brief summary information that theindividual may use to determine which selectable control element toselect. For example, the first selectable control element in the listshown in FIG. 3D comprises a short description of a SNP 316, a graphicalrepresentation of a gene identifier 314 corresponding to the SNP, and agraphical representation of the qualifier 324 a associated with thevariant corresponding to the individual's particular alleles of the SNP.

The short description of the SNP 316 characterizes the biologicalcharacteristic or trait influenced by the corresponding SNP in theindividual's genome. For example, the short description of the SNP 316is “Alcohol Tolerance.” The individual would see that selecting thefirst selectable control element in the list would provide theindividual with information about how the individual's genome influenceshis/her tolerance for alcohol consumption. The individual may select aparticular selectable control element to view detailed information basedon the short description of a SNP and/or the qualifier of the variantcorresponding to his/her particular alleles of the SNP (as displayed bythe graphical representation of the qualifier).

The graphical representation of the qualifier 324 a is a graphic showingeach of the qualifiers associated with the three variants correspondingto the SNP with the qualifier of the particular variant corresponding tothe individual's alleles highlighted. Qualifiers may be words or shortphrases that characterize the variant. For example, “adapt” may be usedto characterize variants that are uncommon and/or disadvantageous;“normal” may be used to characterize variants that are common and/orneither advantageous nor disadvantage; and “gifted” may be used tocharacterize variants that are uncommon and/or advantageous. Thegraphical representation of the qualifier 324 a highlights the qualifierassociated with the variant corresponding to the individual's alleles inred. Different colors may be used to highlight different qualifiers in agraphical representation of a qualifier. For example, in FIG. 3D, whenhighlighted in a graphical representation of a qualifier, “adapt”qualifiers are highlighted in red, “normal” qualifiers are highlightedin blue, and “gifted” qualifiers are highlighted in green.

Some genes have multiple related SNPs. The related SNPs may influence asingle biological characteristic or trait or a plurality of biologicalcharacteristics and/or traits. Each SNP may correspond to a uniqueselectable control element in the assessment GUI. For example, thegraphical representation of the gene identifier 318 appears in twoseparate selectable control elements shown FIG. 3D since at least twounique SNPs relate to the gene corresponding to the graphicalrepresentation of the gene identifier 318. The two unique SNPs aredifferentiated by unique corresponding short descriptions 320 a (“BitterTaste (Part 1)”) and 320 b (“Bitter Taste (Part 2)”). Short descriptions320 a and 320 b correspond to related SNPs that influence anindividual's sensitivity to bitterness in food.

Selecting the first selectable control element identified by shortdescription 316 (“Alcohol Tolerance”) brings the individual to a view ofthe assessment GUI shown in FIG. 3H comprising detailed informationregarding the SNP corresponding to the short description “AlcoholTolerance.” The graphical representation of the gene identifier 328 isshown at the top of the screen. A graphical representation of thequalifier 324 b associated with the variant corresponding to theindividual's particular alleles of the SNP identified in the firstselectable control element. Graphical representation 324 b displays boththat the measurement outcome corresponding to the individual's allelesis “AA” and that the qualifier associated with this variant is “Adapt”.The other two segments of the ring in graphical representation 324 brelate to the other two variants corresponding to the SNP and are colorcoded to the associated qualifiers as described above. The graphicalrepresentation 324 b is an alternative to the graphical representation324 a of FIG. 3D. Graphical control elements 332 a-c indicate themeasurement outcomes associated with each of the three variantscorresponding to the SNP. Graphical control element 332 a indicates thatthe individual's alleles correspond to the variant identified by thedisplayed measurement outcome (by displaying “Your Result” above themeasurement outcome) as well as that information currently displayedbelow the row of graphical control elements 332 a-c is associated withthat variant (by displaying the light blue bar under the measurementoutcome). A portion of description 334 associated with the variantidentified in graphical representation 332 a is visible. An individualmay select other graphical control elements identified by othermeasurement outcomes to view information associated with other variants.

Referring now to FIG. 3F, the individual may scroll in order to readmore information regarding their genome. By scrolling, the completedescription 334 may be read as may other additional information 336,which may be include a brief description associated with a SNP objectcorresponding to the SNP. Scrolling further, an individual can seereferences 338 that provide further detail related to the currentlyselected variant of the SNP object, as shown in FIG. 3G.

The assessment GUI shown in FIGS. 3A-3H is configured for display onmobile devices (e.g., smartphones, tablets, PDAs), but an assessment GUImay also be configured for viewing on a computing device using the web(e.g., with a laptop or desktop computer). The assessment GUI ispopulated using data associated with one or more products. Astandardized graphical user interface element (e.g., widget) is used tocreate data and data structures as well as associations between existingand new data and data structures.

C. Automated Creation of Individual Personal Genetic Profile Assessments

In order to populate an assessment GUI to provide to an individual,genotyping data must be added to the individual's personal geneticprofile assessment. FIG. 4 is a block diagram of a method 400 for addinggenotyping data to an individual's personal genetic profile assessment.In step 410, a processor of a computing device receives genotyping data.In step 420, the processor identifies a gene object corresponding to agene measured in the genotyping data and a SNP object corresponding to aSNP associated with the gene [e.g. the SNP occurring within the gene oroccurring nearby the gene (e.g. within a promotor region that influencestranscription of the gene, e.g. within 5 kb upstream or downstream ofthe gene, e.g. within 100 kb upstream or downstream of the gene, e.g.within 500 kb upstream or downstream of the gene, e.g. within 1 Mbupstream or downstream of the gene)]. In certain embodiments, genotypingdata is stored as a table of data in a text file where each rowcorresponds to a unique SNP. In step 430, a particular variant of SNPrepresented by the identified SNP object and its associated qualifierare determined based on data from genotyping measurements. For example,data corresponding to the measurement outcome of a particular variantmay be stored as one or more columns at the end of each row. In step440, the data is stored in the individual's personal genetic profileassessment. In step 450, the processor determines if all data of thegenotyping data has been stored. If all data has not been stored in theindividual's personal genetic profile assessment, then the methodreturns to step 420. If all data has been stored, then the method ends460. In some embodiments, the processor determines if unstored dataexists by determining if there is a row of data in the genotyping databelow the just processed row.

FIG. 5 shows exemplary genotyping data 500. Genotyping data may take theform of a text file saved by a user, wherein the text file is generatedmanually or as output from equipment for performing genotypingmeasurements (e.g. TaqMan™ SNP genotyping assays). FIG. 5 comprises 6rows of genotyping data from a single biological sample (“RONEN147”).Each row corresponds to data for a different SNP. Each SNP of thegenotyping data 500 is identified by at least a gene identifier 510 anda SNP reference 520. The gene identifier identifies the gene with whichthe SNP is associated. In certain embodiments, multiple (e.g. two ormore) genes are associated with the SNP (e.g. the SNP may occur nearbytwo or more genes and influence phenotypes associated with each of theassociated genes), and, accordingly, two or more corresponding geneidentifiers are listed. Each SNP in the genotyping data has acorresponding variant identified by the allele measurements 530. Themeasurements “allele 1” and “allele 2” for a given SNP may be comparedwith measurement outcomes associated with the variants of a SNP objectcorresponding to the given SNP to populate an individual's personalgenetic profile assessment.

The genotyping data in FIG. 5 used to populate an individual's personalgenetic profile assessment is generated from one or more biologicalsamples of the individual. However, the one or more biological samplesused in populating an individual's personal genetic profile assessmentmay also be taken from a different human or a non-human animal. In someembodiments, genotyping data is generated from one or more biologicalsamples of a non-human animal. For example, an individual may supplybiological samples of their pet in order to understand genomicinformation about the pet to assist in providing better care. The animalmay be a pet or may be an animal cared for by an individual. Forexample, the individual may be a veterinarian or a caretaker at a zoocharged with caring for the animal. In some embodiments, genotyping datais generated from one or more biological samples of a ward to whom theindividual is a guardian. For example, a parent may supply one or morebiological samples to genotyping data for their child in order toimprove his/her childrearing.

Monitoring Meter Levels and Replenishment of Reserves

Genetic material is deposited into a bank, for example, when anindividual provides an organization with one or more additionalbiological samples. As genetic material for each individual is stored asa separate reserve in a bank, the reserve of genetic material of anindividual may be withdrawn from or deposited into as desired withoutimpacting the reserves of other individuals also stored in the bank.

A user may check (e.g., proactively or automatically) the meter valuesfor one or more (e.g., for each) reserves in a bank either individuallyor using certain criteria. For example, a user may enable a meter valuecheck (i.e., meter value determination) that notifies the user to allreserves in a bank that have a meter value below a threshold. Thethreshold may be preset or may be selected by the user. The meter valuecheck may run automatically or may be prompted by the user. An automaticnotification may be the result of a meter value check that runsautomatically with a certain frequency (e.g., daily, weekly, monthly).The notification alerts the user to which individuals with reservesstored in the bank have reserves whose meter value falls below thethreshold. The meter value check may run, for example, each time that awithdrawal or deposit is made or it may be prompted by the purchase of aproduct of a personal genetic profile. The notification may provideidentifying characteristics of the reserves and/or their meter value orit may prompt the user that collection of additional genetic materialfrom individuals with low reserves is needed.

Notifications may alert a user visually (i.e., with a graphical display)or it may alert an individual directly. An individual may be alerted tothe need to provide additional biological sample by an electronic means.For example, an individual may be alerted by email, text message, anin-app notification, a push notification, a phone call, or a voicemail.The individual may be notified of their current meter value or may benotified only qualitatively that their reserve is low.

In certain embodiments, one or more automatic actions are taken when anindividual's reserve is determined to be below an established threshold.In certain embodiments, a kit for providing a replenishment biologicalsample is sent to an individual whose reserve has a meter value isdetermined to be below the established threshold. The kit may be sentbased on a request sent automatically be an organization to a kitsupplier at the instant of determination. For example, the kit may besent from a fulfillment center. In certain embodiments, a letter may besent to an individual informing them of the status of their reserve. Incertain embodiments, an appointment may be scheduled to procure thereplenishment biological sample from the individual when the reserve ofthe individual is determined to be low.

A variety of replenishment biological samples, such as saliva samples,blood samples, cheek cells, urine samples, hair samples, and the like,may be collected from an individual, conveniently in their home, usinginstruments provided in the kit sent to the individual.

For example, the kit may comprise an instrument for obtaining a salivasample, such as a saliva collection tube into which the individual spitsto provide their saliva sample.

For example, the kit may comprise an instrument for collecting a bloodsample. Instruments for collecting a blood sample may include a homefinger prick kit that an individual may use themselves to collect theblood sample via a finger prick. In certain embodiments, phlebotomyinstruments may be provided to the individual e.g., in the form of aportable phlebotomy kit. The individual may be semi-automaticallyscheduled a visit from a phlebotomist or nurse for collection of theblood sample (e.g., the individual may be prompted, via an email,website, app, similar computerized approach, to select one or moreavailable dates for the phlebotomist or nurse visit, and other aspectshandled automatically by the system). The portable phlebotomy kit may besent directly to the individual, or provided by the phlebotomist ornurse at the time of their visit.

In certain embodiments, cheek cells are collected, and the kit comprisesone or more cheek (buccal) swabs that the individual may use to providecheek cell samples.

In certain embodiments, the individual may provide a urine sample may becollected, for example using a urine specimen cup included in the kit.

In certain embodiments, the kit comprises instruments for collecting ahair sample (e.g., comprising one or more hairs), such as tweezersand/or collection tubes.

In certain embodiments, the kit comprises a prepaid, preaddressedmailing envelope for sending the replenishment biological sample to afacility for processing (e.g., extraction of genetic material; e.g.,derivation of iPSCs) and/or storage. In certain embodiments, the kitcomprises a label comprising an anonymous identifier that identifies thereserve of genetic material associated with the individual, butcomprises no other identifying information about the individual. Theanonymous identifier may be, for example, an alphanumeric code or agraphical code (e.g., a barcode; e.g., Quick Response (QR) code) thatidentifies the reserve of genetic material associated with theindividual. The anonymous identifier label can be used to label theindividual's biological sample. The individual may then mail theirreplenishment biological sample with their identity obscured. Withoutany other identifying information on the package or the replenishmentbiological sample provided by the individual, the individual's identitycan thereby be obscured through the entire process from the time whenthey mail their biological sample through when genetic material isextracted and placed in their associated reserve.

In certain embodiments, a user has access to a first bank that storesbiological samples and a second bank that stores genetic material. Whenthe reserve of an individual is determined to have a meter value below acertain threshold, the user may be prompted to generate more geneticmaterial from biological sample of the individual stored in the firstbank. In some embodiments, the prompt comprises adding a task to a labtechnician's task list to extract additional genetic material frombiological sample of the individual soon. For example, biological samplemay be stored as induced pluripotent stem cells (iPSCs) that can be usedto generate additional genetic material when needed by a user. In thisway, for example, the generation of excess genetic material can beavoided and costs to an organization associated with producing geneticmaterial from biological sample can be deferred until necessary.

When a new reserve is added to a bank, an initial meter value isgenerated to be stored in the database for the bank. The initial metervalue may be set by the user using software for interacting with thedatabase. The initial meter value may be determined by a computingdevice, for example, based on an empirical measure received by thecomputing device (e.g., a mass or volume of genetic material and/orsolution containing the genetic material). The empirical measure may begenerated by a measuring apparatus connected (directly or indirectly) tothe computing device. For example, a scale may be connected to acomputer such that the mass of genetic material placed on the scale isreceived by the computer. A user may first indicate on the computer thata new reserve is being added to a bank (e.g., prior to placing thegenetic material in or in the measuring apparatus connected to thecomputer). Such a method may additionally be used when a user isdepositing or withdrawing genetic material from a reserve. For example,a user may need to indicate that a withdrawal is being made prior tomaking the withdrawal. In certain embodiments, a user manually inputs toa computing device amounts of genetic material being deposited (e.g.,initially) or withdrawn from a bank.

An initial amount of genetic material may be estimated from the amountof biological sample used to generate the genetic material. For example,when using an established procedure for generating genetic materialwhere the proportion of genetic material derived from startingbiological sample can be calculated or estimated based on the parametersused in the procedure, the initial known amount of biological sample canbe used to estimate the amount of genetic material that is to be storedin a bank. Such a calculation or estimation may additionally be used toupdate the meter value of a reserve when depositing genetic materialinto the reserve.

Turning to FIG. 6 , an example process 600 for monitoring (e.g.,automatically) amounts of genetic material (e.g. DNA, e.g. RNA) storedin a reserve of genetic material extracted from biological samples ofindividuals (e.g. saliva, e.g. blood, e.g. tissue, e.g. cheek cells(e.g. collected via a cheek (buccal) swab, e.g. urine, e.g. hair, e.g.induced pluripotent stem cells generated from adult cells ofindividuals) is shown. In process 600, in one step a processor of acomputing device stores a meter value for each of a plurality ofindividuals whose genetic material is contained in a bank (602). Themeter values stored for each individual reflects an amount of geneticmaterial stored in a reserve of the individual's genetic material. Asgenetic material is withdrawn and/or deposited, for example as genetictests are run for an individual and/or genetic material is collectedfrom the individual, the processor updates the meter value for thereserve of the individual's genetic material (604). As meter values areupdated, the processor determines whether they are below a particularminimum threshold for an amount of genetic material to be maintained inthe reserves (606). If a meter value for a particular reserve isdetermined to be below the minimum threshold, a notification istriggered to indicate that collection of additional material from thecorresponding individual is needed (608).

Computer System and Network Architecture

As shown in FIG. 7 , an implementation of a network environment 700 foruse in providing systems, methods, and architectures described herein isshown and described. In brief overview, referring now to FIG. 7 , ablock diagram of an exemplary cloud computing environment 700 is shownand described. The cloud computing environment 700 may include one ormore resource providers 702 a, 702 b, 702 c (collectively, 702). Eachresource provider 702 may include computing resources. In someimplementations, computing resources may include any hardware and/orsoftware used to process data. For example, computing resources mayinclude hardware and/or software capable of executing algorithms,computer programs, and/or computer applications. In someimplementations, exemplary computing resources may include applicationservers and/or databases with storage and retrieval capabilities. Eachresource provider 702 may be connected to any other resource provider702 in the cloud computing environment 700. In some implementations, theresource providers 702 may be connected over a computer network 708.Each resource provider 702 may be connected to one or more computingdevice 704 a, 704 b, 704 c (collectively, 704), over the computernetwork 708.

The cloud computing environment 700 may include a resource manager 706.The resource manager 706 may be connected to the resource providers 702and the computing devices 704 over the computer network 708. In someimplementations, the resource manager 706 may facilitate the provisionof computing resources by one or more resource providers 702 to one ormore computing devices 704. The resource manager 706 may receive arequest for a computing resource from a particular computing device 704.The resource manager 706 may identify one or more resource providers 702capable of providing the computing resource requested by the computingdevice 704. The resource manager 706 may select a resource provider 702to provide the computing resource. The resource manager 706 mayfacilitate a connection between the resource provider 702 and aparticular computing device 704. In some implementations, the resourcemanager 706 may establish a connection between a particular resourceprovider 702 and a particular computing device 704. In someimplementations, the resource manager 706 may redirect a particularcomputing device 704 to a particular resource provider 702 with therequested computing resource.

FIG. 8 shows an example of a computing device 800 and a mobile computingdevice 850 that can be used to implement the techniques described inthis disclosure. The computing device 800 is intended to representvarious forms of digital computers, such as laptops, desktops,workstations, personal digital assistants, servers, blade servers,mainframes, and other appropriate computers. The mobile computing device850 is intended to represent various forms of mobile devices, such aspersonal digital assistants, cellular telephones, smart-phones, andother similar computing devices. The components shown here, theirconnections and relationships, and their functions, are meant to beexamples only, and are not meant to be limiting.

The computing device 800 includes a processor 802, a memory 804, astorage device 806, a high-speed interface 808 connecting to the memory804 and multiple high-speed expansion ports 810, and a low-speedinterface 812 connecting to a low-speed expansion port 814 and thestorage device 806. Each of the processor 802, the memory 804, thestorage device 806, the high-speed interface 808, the high-speedexpansion ports 810, and the low-speed interface 812, are interconnectedusing various busses, and may be mounted on a common motherboard or inother manners as appropriate. The processor 802 can process instructionsfor execution within the computing device 800, including instructionsstored in the memory 804 or on the storage device 806 to displaygraphical information for a GUI on an external input/output device, suchas a display 816 coupled to the high-speed interface 808. In otherimplementations, multiple processors and/or multiple buses may be used,as appropriate, along with multiple memories and types of memory. Also,multiple computing devices may be connected, with each device providingportions of the necessary operations (e.g., as a server bank, a group ofblade servers, or a multi-processor system). Thus, as the term is usedherein, where a plurality of functions are described as being performedby “a processor”, this encompasses embodiments wherein the plurality offunctions are performed by any number of processors (one or more) of anynumber of computing devices (one or more). Furthermore, where a functionis described as being performed by “a processor”, this encompassesembodiments wherein the function is performed by any number ofprocessors (one or more) of any number of computing devices (one ormore) (e.g., in a distributed computing system).

The memory 804 stores information within the computing device 800. Insome implementations, the memory 804 is a volatile memory unit or units.In some implementations, the memory 804 is a non-volatile memory unit orunits. The memory 804 may also be another form of computer-readablemedium, such as a magnetic or optical disk.

The storage device 806 is capable of providing mass storage for thecomputing device 800. In some implementations, the storage device 806may be or contain a computer-readable medium, such as a floppy diskdevice, a hard disk device, an optical disk device, or a tape device, aflash memory or other similar solid state memory device, or an array ofdevices, including devices in a storage area network or otherconfigurations. Instructions can be stored in an information carrier.The instructions, when executed by one or more processing devices (forexample, processor 802), perform one or more methods, such as thosedescribed above. The instructions can also be stored by one or morestorage devices such as computer- or machine-readable mediums (forexample, the memory 804, the storage device 806, or memory on theprocessor 802).

The high-speed interface 808 manages bandwidth-intensive operations forthe computing device 800, while the low-speed interface 812 manageslower bandwidth-intensive operations. Such allocation of functions is anexample only. In some implementations, the high-speed interface 808 iscoupled to the memory 804, the display 816 (e.g., through a graphicsprocessor or accelerator), and to the high-speed expansion ports 810,which may accept various expansion cards (not shown). In theimplementation, the low-speed interface 812 is coupled to the storagedevice 806 and the low-speed expansion port 814. The low-speed expansionport 814, which may include various communication ports (e.g., USB,Bluetooth®, Ethernet, wireless Ethernet) may be coupled to one or moreinput/output devices, such as a keyboard, a pointing device, a scanner,or a networking device such as a switch or router, e.g., through anetwork adapter.

The computing device 800 may be implemented in a number of differentforms, as shown in the figure. For example, it may be implemented as astandard server 820, or multiple times in a group of such servers. Inaddition, it may be implemented in a personal computer such as a laptopcomputer 822. It may also be implemented as part of a rack server system824. Alternatively, components from the computing device 800 may becombined with other components in a mobile device (not shown), such as amobile computing device 850. Each of such devices may contain one ormore of the computing device 800 and the mobile computing device 850,and an entire system may be made up of multiple computing devicescommunicating with each other.

The mobile computing device 850 includes a processor 852, a memory 864,an input/output device such as a display 854, a communication interface866, and a transceiver 868, among other components. The mobile computingdevice 850 may also be provided with a storage device, such as amicro-drive or other device, to provide additional storage. Each of theprocessor 852, the memory 864, the display 854, the communicationinterface 866, and the transceiver 868, are interconnected using variousbuses, and several of the components may be mounted on a commonmotherboard or in other manners as appropriate.

The processor 852 can execute instructions within the mobile computingdevice 850, including instructions stored in the memory 864. Theprocessor 852 may be implemented as a chipset of chips that includeseparate and multiple analog and digital processors. The processor 852may provide, for example, for coordination of the other components ofthe mobile computing device 850, such as control of user interfaces,applications run by the mobile computing device 850, and wirelesscommunication by the mobile computing device 850.

The processor 852 may communicate with a user through a controlinterface 858 and a display interface 856 coupled to the display 854.The display 854 may be, for example, a TFT (Thin-Film-Transistor LiquidCrystal Display) display or an OLED (Organic Light Emitting Diode)display, or other appropriate display technology. The display interface856 may comprise appropriate circuitry for driving the display 854 topresent graphical and other information to a user. The control interface858 may receive commands from a user and convert them for submission tothe processor 852. In addition, an external interface 862 may providecommunication with the processor 852, so as to enable near areacommunication of the mobile computing device 850 with other devices. Theexternal interface 862 may provide, for example, for wired communicationin some implementations, or for wireless communication in otherimplementations, and multiple interfaces may also be used.

The memory 864 stores information within the mobile computing device850. The memory 864 can be implemented as one or more of acomputer-readable medium or media, a volatile memory unit or units, or anon-volatile memory unit or units. An expansion memory 874 may also beprovided and connected to the mobile computing device 850 through anexpansion interface 872, which may include, for example, a SIMM (SingleIn Line Memory Module) card interface. The expansion memory 874 mayprovide extra storage space for the mobile computing device 850, or mayalso store applications or other information for the mobile computingdevice 850. Specifically, the expansion memory 874 may includeinstructions to carry out or supplement the processes described above,and may include secure information also. Thus, for example, theexpansion memory 874 may be provide as a security module for the mobilecomputing device 850, and may be programmed with instructions thatpermit secure use of the mobile computing device 850. In addition,secure applications may be provided via the SIMM cards, along withadditional information, such as placing identifying information on theSIMM card in a non-hackable manner.

The memory may include, for example, flash memory and/or NVRAM memory(non-volatile random access memory), as discussed below. In someimplementations, instructions are stored in an information carrier, thatthe instructions, when executed by one or more processing devices (forexample, processor 852), perform one or more methods, such as thosedescribed above. The instructions can also be stored by one or morestorage devices, such as one or more computer- or machine-readablemediums (for example, the memory 864, the expansion memory 874, ormemory on the processor 852). In some implementations, the instructionscan be received in a propagated signal, for example, over thetransceiver 868 or the external interface 862.

The mobile computing device 850 may communicate wirelessly through thecommunication interface 866, which may include digital signal processingcircuitry where necessary. The communication interface 866 may providefor communications under various modes or protocols, such as GSM voicecalls (Global System for Mobile communications), SMS (Short MessageService), EMS (Enhanced Messaging Service), or MMS messaging (MultimediaMessaging Service), CDMA (code division multiple access), TDMA (timedivision multiple access), PDC (Personal Digital Cellular), WCDMA(Wideband Code Division Multiple Access), CDMA2000, or GPRS (GeneralPacket Radio Service), among others. Such communication may occur, forexample, through the transceiver 868 using a radio-frequency. Inaddition, short-range communication may occur, such as using aBluetooth®, Wi-Fi™, or other such transceiver (not shown). In addition,a GPS (Global Positioning System) receiver module 870 may provideadditional navigation- and location-related wireless data to the mobilecomputing device 850, which may be used as appropriate by applicationsrunning on the mobile computing device 850.

The mobile computing device 850 may also communicate audibly using anaudio codec 860, which may receive spoken information from a user andconvert it to usable digital information. The audio codec 860 maylikewise generate audible sound for a user, such as through a speaker,e.g., in a handset of the mobile computing device 850. Such sound mayinclude sound from voice telephone calls, may include recorded sound(e.g., voice messages, music files, etc.) and may also include soundgenerated by applications operating on the mobile computing device 850.

The mobile computing device 850 may be implemented in a number ofdifferent forms, as shown in the figure. For example, it may beimplemented as a cellular telephone 880. It may also be implemented aspart of a smart-phone 882, personal digital assistant, or other similarmobile device.

Various implementations of the systems and techniques described here canbe realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof.These various implementations can include implementation in one or morecomputer programs that are executable and/or interpretable on aprogrammable system including at least one programmable processor, whichmay be special or general purpose, coupled to receive data andinstructions from, and to transmit data and instructions to, a storagesystem, at least one input device, and at least one output device.

These computer programs (also known as programs, software, softwareapplications or code) include machine instructions for a programmableprocessor, and can be implemented in a high-level procedural and/orobject-oriented programming language, and/or in assembly/machinelanguage. As used herein, the terms machine-readable medium andcomputer-readable medium refer to any computer program product,apparatus and/or device (e.g., magnetic discs, optical disks, memory,Programmable Logic Devices (PLDs)) used to provide machine instructionsand/or data to a programmable processor, including a machine-readablemedium that receives machine instructions as a machine-readable signal.The term machine-readable signal refers to any signal used to providemachine instructions and/or data to a programmable processor.

To provide for interaction with a user, the systems and techniquesdescribed here can be implemented on a computer having a display device(e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor)for displaying information to the user and a keyboard and a pointingdevice (e.g., a mouse or a trackball) by which the user can provideinput to the computer. Other kinds of devices can be used to provide forinteraction with a user as well; for example, feedback provided to theuser can be any form of sensory feedback (e.g., visual feedback,auditory feedback, or tactile feedback); and input from the user can bereceived in any form, including acoustic, speech, or tactile input.

The systems and techniques described here can be implemented in acomputing system that includes a back end component (e.g., as a dataserver), or that includes a middleware component (e.g., an applicationserver), or that includes a front end component (e.g., a client computerhaving a graphical user interface or a Web browser through which a usercan interact with an implementation of the systems and techniquesdescribed here), or any combination of such back end, middleware, orfront end components. The components of the system can be interconnectedby any form or medium of digital data communication (e.g., acommunication network). Examples of communication networks include alocal area network (LAN), a wide area network (WAN), and the Internet.

The computing system can include clients and servers. A client andserver are generally remote from each other and typically interactthrough a communication network. The relationship of client and serverarises by virtue of computer programs running on the respectivecomputers and having a client-server relationship to each other.

In some implementations, modules described herein can be separated,combined or incorporated into single or combined modules. Any modulesdepicted in the figures are not intended to limit the systems describedherein to the software architectures shown therein.

It is contemplated that systems, architectures, devices, methods, andprocesses of the claimed invention encompass variations and adaptationsdeveloped using information from the embodiments described herein.Adaptation and/or modification of the systems, architectures, devices,methods, and processes described herein may be performed, ascontemplated by this description.

Throughout the description, where articles, devices, systems, andarchitectures are described as having, including, or comprising specificcomponents, or where processes and methods are described as having,including, or comprising specific steps, it is contemplated that,additionally, there are articles, devices, systems, and architectures ofthe present invention that consist essentially of, or consist of, therecited components, and that there are processes and methods accordingto the present invention that consist essentially of, or consist of, therecited processing steps.

It should be understood that the order of steps or order for performingcertain action is immaterial so long as the invention remains operable.Moreover, two or more steps or actions may be conducted simultaneously.

The mention herein of any publication, for example, in the Backgroundsection, is not an admission that the publication serves as prior artwith respect to any of the claims presented herein. The Backgroundsection is presented for purposes of clarity and is not meant as adescription of prior art with respect to any claim.

Documents are incorporated herein by reference as noted. Where there isany discrepancy in the meaning of a particular term, the meaningprovided in the Definition section above is controlling.

What is claimed is:
 1. A method of monitoring amounts of geneticmaterial stored in a reserve of genetic material extracted frombiological samples of individuals, the method comprising: for each of aplurality of individuals whose genetic material is contained in a bank,storing, by a processor of a computing device, a meter value thatreflects an amount of the genetic material stored in a reserve of eachindividual's genetic material; for each of one or more withdrawals ordeposits of genetic material from/into the bank, updating, by theprocessor, the meter value of corresponding reserve(s) of geneticmaterial to reflect an amount of genetic material remaining in thecorresponding reserve(s); and determining, by the processor, for each ofa plurality of reserves in the bank, whether the meter value is below aminimum threshold of an amount of genetic material to be maintained inthe reserve of an individual.
 2. The method of claim 1, furthercomprising: responsive to determining that the meter value is below aminimum threshold value for a given reserve, triggering, by theprocessor, a notification.
 3. The method of claim 2, wherein thetriggering of the notification comprises issuing an alert of low reserveamount.
 4. The method of claim 2, wherein triggering the notificationcomprises automatically issuing, by the processor, a request to supplythe individual associated with the reserve with a kit for providing areplenishment biological sample.
 5. The method of claim 4, wherein thekit comprises one or more instruments for collection of thereplenishment biological sample from the individual associated with thereserve.
 6. The method of claim 5, wherein the one or more instrumentsincludes one or more cheek (buccal) swabs.
 7. The method of claim 1,further comprising, responsive to determining that the meter value isbelow a minimum threshold value for a given reserve, replenishing thegiven reserve with additional genetic material extracted from abiological sample from the individual associated with the reserve. 8.The method of claim 7, wherein the additional genetic material isextracted from induced pluripotent stem cells generated from adult cellsfrom the individual associated with the reserve.
 9. The method of claim1, comprising, initially: for each of a plurality of individuals,receiving, by the processor, an initial value reflecting an amount ofgenetic material initially present in the reserve of genetic materialassociated with the individual; and storing, by the processor, thereceived initial value as the meter value.
 10. The method of claim 9,wherein the initial value is based on an amount of genetic materialextracted from a corresponding biological sample from the individualassociated with the reserve and deposited in the reserve.
 11. The methodof claim 1, comprising, for each of the one or more withdrawals:receiving, by the processor, a usage value that reflects the amount ofgenetic material removed in the withdrawal; and updating, by theprocessor, the meter value for the corresponding reserve using the usagevalue.
 12. A system for monitoring amounts of genetic material stored ina reserve of genetic material extracted from biological samples ofindividuals, the system comprising: a processor; and a non-transitorycomputer readable memory having instructions stored thereon, wherein theinstructions, when executed by the processor, cause the processor to:for each of a plurality of individuals whose genetic material iscontained in a bank, store, by the processor, a meter value thatreflects an amount of the genetic material stored in a reserve of eachindividual's genetic material; for each of one or more withdrawals ordeposits of genetic material from/into the bank, update, by theprocessor, the meter value of corresponding reserve(s) of geneticmaterial to reflect an amount of genetic material remaining in thecorresponding reserve(s); and determine, by the processor, for each of aplurality of reserves in the bank, whether the meter value is below aminimum threshold of an amount of genetic material to be maintained inthe reserve of an individual.
 13. The system of claim 12, wherein theinstructions, when executed by the processor, cause the processor to:responsive to determining that the meter value is below a minimumthreshold value for a given reserve, trigger, by the processor, anotification.
 14. The system of claim 13, wherein the instructions, whenexecuted by the processor, cause the processor to: when triggering thenotification, issue an alert of low reserve amount.
 15. The system ofclaim 13, wherein the instructions, when executed by the processor,cause the processor to: when triggering the notification, automaticallyissue, by the processor, a request to supply the individual associatedwith the reserve with a kit for providing a replenishment biologicalsample.
 16. The system of claim 15, wherein the kit comprises one ormore instruments for collection of the replenishment biological samplefrom the individual associated with the reserve.
 17. The system of claim16, wherein the one or more instruments includes one or more cheek(buccal) swabs.
 18. The system of claim 12, wherein the instructions,when executed by the processor, cause the processor to, initially: foreach of a plurality of individuals, receive, by the processor, aninitial value reflecting an amount of genetic material initially presentin the reserve of genetic material associated with the individual; andstore, by the processor, the received initial value as the meter value.19. The system of claim 18, wherein the initial value is based on anamount of genetic material extracted from a corresponding biologicalsample from the individual associated with the reserve and deposited inthe reserve.
 20. The system of claim 12, wherein the instructions, whenexecuted by the processor, cause the processor to, for each of the oneor more withdrawals: receive, by the processor, a usage value thatreflects the amount of genetic material removed in the withdrawal; andupdate, by the processor, the meter value for the corresponding reserveusing the usage value.